Gut Microbiota, "Spark and Flame" of COVID-19 Disease

August 21, 2020 updated by: Universidade Nova de Lisboa
Elderly, hypertension, diabetes and cardiovascular diseases are risk factors for COVID-19 morbility and mortality. However, the real reason for this is not yet understood. It is well documented that gut microbiota has a critical role in health, particularly in the immune system and therefore, we propose that gut microbiota composition could affect vulnerability and disease outcomes of COVID-19.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In order to explore this hypothesis, we will analyse the gut microbiota of SARSCoV-2 infected patients categorized according to location: [1] ambulatory (self-isolation at home), [2] ward and [1] ICU; and severity.

Study Type

Observational

Enrollment (Actual)

115

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Lisbon, Portugal
        • Hospital CUF Infante Santo, S.A.
      • Lisbon, Portugal
        • Hospital de São Francisco Xavier
      • Oporto, Portugal
        • Centro Hospitalar Universitario Sao Joao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

COVID-19 patients admitted to Portuguese hospitals.

Description

Inclusion Criteria:

  • Adults of 18 years and above.
  • COVID-19 patients.

Exclusion Criteria:

  • None.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ambulatory
Patients that are self-isolated at home
Other: Exposure
Individuals with SARS-CoV-2 exposure and COVID-19 symptoms.
Ward
Patients that are in an isolated room at the hospital
Other: Exposure
Individuals with SARS-CoV-2 exposure and COVID-19 symptoms.
ICU
Patients that are in the ICU of the hospital
Other: Exposure
Individuals with SARS-CoV-2 exposure and COVID-19 symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Differences in gut microbiota composition between COVID-19 patients with different degrees of disease severity.
Time Frame: Stool samples of COVID-19 patients will be collected after subject enrollment (single point collection)
Stool samples of COVID-19 patients will be collected after subject enrollment (single point collection)

Secondary Outcome Measures

Outcome Measure
Time Frame
Differences in gut microbiota composition between COVID-19 patients in relation to mortality.
Time Frame: Through study completion, an average of 3 months.
Through study completion, an average of 3 months.
Differences in gut microbiota composition between COVID-19 patients in relation to length of stay in hospitals.
Time Frame: Through study completion, an average of 3 months.
Through study completion, an average of 3 months.
Differences in gut microbiota composition between COVID-19 patients in relation to duration of mechanical ventilation.
Time Frame: Through study completion, an average of 3 months.
Through study completion, an average of 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Nova de Lisboa

Collaborators

CINTESIS - Center for Health Technology and Services Research
Hospital de São Francisco Xavier, Centro Hospitalar de Lisboa Ocidental
Centro Hospitalar Universitário São João
CUF Academic and Research Medical Center
Hospital CUF Infante Santo, S.A.
Centro de Medicina Laboratorial Germano de Sousa, S.A.

Investigators

  • Principal Investigator: Pedro Póvoa, PhD, Hospital São Francisco Xavier
  • Principal Investigator: Cristina Granja, PhD, Centro Hospitalar Universitario Sao Joao
  • Principal Investigator: Maria JR Sousa, PhD, Centro de Medicina Laboratorial Germano de Sousa, S.A.
  • Study Chair: José Leal, PhD, Centro de Medicina Laboratorial Germano de Sousa, S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2020

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

July 16, 2020

Study Registration Dates

First Submitted

April 15, 2020

First Submitted That Met QC Criteria

April 17, 2020

First Posted (Actual)

April 21, 2020

Study Record Updates

Last Update Posted (Actual)

August 25, 2020

Last Update Submitted That Met QC Criteria

August 21, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID19_Microbiota

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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